A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02788916
• Collaborator: (none)
• Enrollment: 198
• Locations: 10
• Actual Duration (Months): 15.6
• Patients Per Site: 19.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Peripheral	Other: No Intervention

Detailed Description

This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).

This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.

Study Design

• Study Type: Observational
• Actual Enrollment: 198 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population
• Actual Study Start Date: Sep 25, 2015
• Actual Primary Completion Date: Nov 10, 2016
• Actual Study Completion Date: Jan 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Assessment of tumor biopsies and histological preparations of participants diagnosed with peripheral T-cell lymphoma (PTCL) in the six years between 01 January 2008 and 31 December 2013 will be performed.	Other: No Intervention

Outcome Measures

Primary Outcome Measures

1. Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes [Up to 6 months]

   Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.

Secondary Outcome Measures

1. Percentage of Participants with Each Subtypes of PTCL [Up to 6 months]

   Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.

2. Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification [Up to 6 months]

   Rate of discrepancy between the initial diagnosis of PTCL in participants and diagnosis by re-analysis and re-classification according to the WHO 2008 classification will be determined.

3. Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL [Up to 6 months]

   Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.

4. Correlation Between the Expression of CD30 and Lymphoid Lineage [Up to 6 months]

   Markers of T and B cells will be used in order to determine if CD30 expression occurs in tumor cells or other B-lineage.

5. Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival [Up to 6 months]

   Survival includes progression free survival: period from date of start of treatment until tumor progression or death, whichever occurs first. Overall survival: period from date of diagnosis to the date of death.

6. Classification of Peripheral T-cell Lymphoma [Up to 6 months]

   The PTCL is classified according to the expression of CD30 and T-Cell Receptor ß (TCRß) and T-Cell Receptor γ (TCRγ) by immunohistochemistry (IHC).

7. T-cell Clonality in PTCL [Up to 6 months]

   Analysis of T-cell clonality in PTCL will be performed. Clonality defines the profile of gene rearrangement of T cell receptor and allow establishing whether proliferation is monoclonal.

8. Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors [Up to 6 months]

   Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.

• Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).

• PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:

• Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type

• Enteropathic T-cell lymphoma

• Hepatosplenic T-cell lymphoma

• Peripheral T-cell lymphoma, not otherwise specified

• Angioimmunoblastic T-cell lymphoma

• Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+

• Anaplastic large cell lymphoma, ALK-

Exclusion Criteria:

• Participants with an unavailable history (lost, empty or not recoverable).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Santiago de Compostela	A Coruna	Spain
2		Majadahonda	Madrid	Spain
3		Barcelona		Spain
4		Cordoba		Spain
5		Madrid		Spain
6		Oviedo		Spain
7		Salamanca		Spain
8		Santander		Spain
9		Sevilla		Spain
10		Valencia		Spain

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director Clinical Science, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02788916
• Other Study ID Numbers: Brentuximab-5012; TAK-HEM-2015-01
• First Posted: Jun 2, 2016
• Last Update Posted: Mar 21, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Takeda: Drug Therapy
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Mar 21, 2017